The purpose of this study is to determine whether using LY4052031 in a type of cancer that may have tumor cells that express a protein called Nectin-4 is safe and how well the cancer responds to the study drug. LY4052031 has not been approved by the US Food and Drug Administration (FDA). This is a first in human study and all of the risks are not fully…
You may want to join this study because your heart condition may respond to a device-based therapy called cardiac modulation therapy called the OPTIMIZER System. The OPTIMIZER INTEGRA CCM-D System, also known as a Cardiac Contractility Modulation Defibrillator, is an investigational device system that combines CCM therapy and ICD therapy into one device.…
This study is being done to answer the following question: Can we lower the chance of your bladder cancer growing or spreading by using one type of chemotherapy instilled in the bladder, Gemcitabine and Docetaxel, instead of the usual therapy? The usual approach for patients who are not in a study is treatment with Transurethral surgery of bladder tumor (…
The ALLEVIATE-HF study is a prospective, randomized, multi-site, interventional, investigational device exemption (IDE) study. The purpose of the study is to gain experience with utilization of an integrated device diagnostic-based risk stratification algorithm to guide patient care in subjects with NYHA class II and III heart failure. The study will…
We are doing this study to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic (not providing therapy) features for the insertable cardiac monitor (ICM) systems. ICMs are small devices implanted under the skin and are now widely used for the long-term monitoring and detection of abnormal heart rhythms. ICMs…
This study is for patients who have bladder cancer that has not invaded muscle tissue and who have been treated with one or more surgical resections and Bacillus Calmette-Guerin or BCG, which was directly given into the bladder before. The main purpose of this trial is to show that durvalumab is safe when given alone, in combination with BCG treatments, and…
The purpose of this research study is to understand if aspirin is needed in patients heart failure implanted with the HeartMate 3. Patients with devices like the HeartMate 3 take two blood thinner medicines, specifically warfarin and aspirin. Patients implanted with devices like the HeartMate 3 experience both clotting and bleeding complications. Data…
We are seeking adults with cardiovascular disease who identify as Black/African American or LatinX, and/or their caregivers, as well as community health workers working in primarily Black/African American or LatinX neighborhoods of NYC, to participate in a brief (30-minute) interviews over the phone or Zoom to discuss attitudes and perceptions related to…
We are doing this research to find out the safety, toxicity, and efficacy of intravesical Cabazitaxel, Gemcitabine, and Cisplatin (CGC) in the treatment of non-muscle-invasive urothelial carcinoma of the bladder that has recurred despite BCG use. The purpose of finding the maximum tolerable dose is important for future use of the drug, so as to provide the…
The purpose of this research is to evaluate the safety and performance of an experimental system called the Aortix System. The system is being designed for use in patients hospitalized for a worsening of their heart failure symptoms and who also show signs of strain on their kidneys. The Aortix System includes a pump, which we hope may help the heart and…
This is a Phase 1 study (the first time this treatment is being tested in humans) of an anti-cancer study drug called as PF-07225570. This study drug works on stimulating certain cells in the immune system. The study will test different doses that increase (dose escalation) and at the appropriate time, additional patients will be enrolled to evaluate this…
This research study will investigate an experimental, unapproved drug that will be given two different ways; as an injection in the bladder wall after bladder tumor resection surgery (or TURBT) and then as an intravesical instillation (fluid inserted in the bladder by catheter) right after the injection. The purpose of this study is to find the dose which…
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening…
This clinical trial is for patients who have cancer of the urinary system (urothelial cancer, including cancer of the bladder, renal pelvis, ureter or urethra) that has spread to nearby tissues or to other areas of the body who have already been treated with a kind of anticancer drug called an immune checkpoint inhibitor (CPI). This clinical trial uses an…
Glaucoma is a given name of a group of diseases that affect the retinal ganglion cells in the eye and the optic nerve. Glaucoma cause degeneration of the retinal ganglion cells in the retina and their projections (axons) that form the optic nerve. Retinal ganglion cells and their axons transmit all of our vision information from the eye to the brain through…
The purpose of this study is to look at a new treatment for non-muscle-invasive bladder cancer. This new form of paclitaxel, a drug currently used by injection into a vein to treat various types of cancer, is designed to be instilled (injected) into the urinary bladder with a catheter (tube) placed into your bladder through your urethra (the opening where…
The purpose of this study is to evaluate the NuPulseCV intravascular ventricular assist system (iVAS), a device similar to an Intra-aortic Balloon Pump (IABP) that helps circulate blood from the heart throughout the rest of the body. This study aims to: (1) See if the iVAS improves your blood circulation (2) Better understand how the iVAS device could…
This study is being conducted to evaluate the performance of the AssureMDx test for the detection of bladder cancer in patients presenting with hematuria.
The purpose of the study is to characterize von Willebrand Factor (VWF) profiles in patients receiving HeartMate 3 (HM3) and compare them to HeartMate II (HMII) Left Ventricular Assist Device (LVAD).
The purposes of this clinical study are: To evaluate the safety and tolerability of up to 2 drug release periods of GemRIS for up to 7 days per drug release period To evaluate the pharmacokinetics (the study of the bodily absorption, distribution, metabolism, and excretion of the drug) of gemcitabine and a gemcitabine-related metabolite (product after…
The study is part of a research program to assess the efficacy of the drug nab-rapamycin, a biologic mTOR inhibitor. The purpose of the study is to assess the response rate, as well as, the safety of administering nab-rapamycin in combination with gemcitabine directly into the bladder in an effort to treat bladder cancer. The study seeks to determine if…
This research is being done to study the effects, safety, and tolerability of the study drugs Nivolumab and Urelumab when given to people with advanced bladder cancer that has spread into the muscle tissue, also called Muscle-Invasive Urothelial Carcinoma of the Bladder (MIBC). Specifically, this research study will have participants either take Nivolumab…
This study is for patients with Glaucoma. The purpose of this study is to investigate the safety and effectiveness of a study drug called Bimatoprost Sustained Release (SR) compared to treatment with eye drug Timolol. The Bimatoprost SR is an implant that is very small, is biodegradable (dissolves naturally in the body), and contains the bimatoprost drug.
The purpose of this study is to test how well the drug works, safety, and side effects of the experimental drug called BMS-986205. BMS-986205 will be added to another cancer medicine called nivolumab plus chemotherapy for participants who have bladder cancer that has grown into the muscle wall of the bladder. These drugs will be compared to just…